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Modesa Acne Treatment by Zhejiang Jingwei Pharmaceutic Al Co., Ltd.

Medically reviewed on August 3, 2017

Dosage form: cream
Ingredients: BENZOYL PEROXIDE 1g in 100g
Labeler: Zhejiang Jingwei Pharmaceutic Al Co., Ltd.
NDC Code: 55621-015

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Active ingredients

Benzoyl peroxide  10%

Purpose

Acne medication

Uses  for the treatment and prevention of acne pimples

Warnings

•For external use only

Do not use

•if you have sensitive skin or are sensitive to benzoyl peroxide

When using this product

•avoid contact with eyes, lips and mouth •avoid contact

with hair or dyed fabrics including carpet and clothing which

may be bleached by this product  •with other topical acne

medicaitons, at the same time nor immediately following use

of this product, increased dryness or irritation of the skin

may occur. If this occurs, only one medicaiton should be used

unless directed by a doctor  •skin irritaiton may occur,

characterized by redness, burning, itching, peeling or possibly

swelling. More frequent use or higher concentration may

aggravtae skin irritation. Mild irritation may be reduced by

using the product less frequently or in a lower concentration

•avoid unnecessary sun exposure and use a sunscreen

Stop use and ask a doctor

•if skin irritation becomes severe

Keep out of reach of children.  In case of accidental ingestion,

get medical help or contact a Poison Control Center immediately.

Directions

•cleanse the skin thoroughly before applying medication

•cover the entire affected area with a thin layer one to three

times a day

•because excessive drying of the skin may occur, start with

one applicaiton daily, then gradually increase to two to three

times daily if needed or as directed by a doctor. If bothersome

dryness or peeling occurs, reduce application to once a day or

every other day

•if going outside, apply sunscreen after using this product. If

irritation or sensitivity develops, stop use of both products and

ask a doctor

Other information  •keep tightly closed

•store at room temperature 68° - 86° F (20° - 30°C).

Inactive ingredients  aluminum hydroxide, bentonite,

carbomer, glycerin monostearate, isopropyl myristate,

methylparaben, peg-12, potassium hydroxide, propylene glycol,

propylparaben, water

Questions?  1-800-639-3803 Weekdays 9 AM to 4 PM EST

MODESA  ACNE TREATMENT
benzoyl peroxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55621-015
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOYL PEROXIDE (BENZOYL PEROXIDE) BENZOYL PEROXIDE1 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
ALUMINUM HYDROXIDE 
BENTONITE 
CARBOMER 940 
DIGLYCERIN MONOSTEARATE 
METHYLPARABEN 
POLYETHYLENE GLYCOL 600 
POTASSIUM HYDROXIDE 
PROPYLENE GLYCOL 
PROPYLPARABEN 
WATER 
Packaging
#Item CodePackage Description
1NDC:55621-015-011 TUBE in 1 CARTON
128 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333D08/03/2017
Labeler - Zhejiang Jingwei Pharmaceutic Al Co., Ltd. (530876549)
Establishment
NameAddressID/FEIOperations
Zhejiang Jingwei Pharmaceutic Al Co., Ltd.530876549manufacture(55621-015)

 
Zhejiang Jingwei Pharmaceutic Al Co., Ltd.

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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